Attachment 5 IRB Approvals

Form Approved

OMB No. 0920-XXX

Expiration Date XX/XX/20XX

ATTACHMENT 5:
CDC AND RTI INSTITUTIONAL REVIEW BOARD APPROVAL

DATE:       7/24/2007

FROM:       IRB-C Administrator
            Human Research Protection Office
                Office of Scientific Regulatory Services
            Office of the Chief Science Officer, OD/CDC

SUBJECT:    Site Restricted - IRB Approval of New Protocol #5176, "Formative Reserch to Inform an HIV Testing Social Marketing Campaign for African American Heterosexual Men" (Expedited)

TO:         DONATA GREEN    [DQG7]
            NCHSTP/

New protocol #5176 has been approved by CDC IRB "C" for the maximum allowable period of one year and it will expire on 7/23/2008.  The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), category 7.  The Board determined that the study poses no greater than minimal risk to subjects. 

The Board also approved a waiver of documentation of informed consent for the telephone screener in accordance with 45 CFR 46.117(c)(2).

Collaborator Site Restriction: Study activities may not begin with the following collaborator/site until documentation indicating current IRB approval has been received by CDC’s Human Research Protection Office and is on file: 

RTI International
 
If other institutions involved in this protocol are being awarded CDC funds through the CDC Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to the CDC PGO award specialist handling the award.  You are also required to verify with the award specialist that the awardee has provided PGO with the required documentation and has approval to begin or continue research involving human subjects as described in this protocol.

As a reminder, the IRB must review and approve all human subjects research protocols at intervals appropriate to the degree of risk, but not less than once per year.  There is no grace period beyond one year from the last IRB approval date.  It is ultimately your responsibility to submit your research protocol for continuation review and approval by the IRB.  Please keep this approval in your protocol file as proof of IRB approval and as a reminder of the expiration date.  To avoid lapses in approval of your research and the possible suspension of subject enrollment and/or termination of the protocol, please submit your continuation request at least six weeks before the protocol's expiration date of 7/23/2008.

Any problems of a serious nature should be brought to the immediate attention of the IRB, and any proposed changes to the protocol should be submitted as an amendment to the protocol for IRB approval before they are implemented.

If you have any questions, please contact the Human Research Protection Office at (404) 639-4954 or e-mail: huma@cdc.gov.

Jennifer McCleary

cc:
Jim Jones
NCHSTP Human Subjects
Laura Youngblood

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